federal_register: 2021-26733

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2021-26733 Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this draft guidance addresses FDA's current recommendations regarding trial design, safety, and efficacy considerations for CRSwNP clinical trials. 2021-12-10 2021 12 https://www.federalregister.gov/documents/2021/12/10/2021-26733/chronic-rhinosinusitis-with-nasal-polyps-developing-drugs-for-treatment-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2021-12-10/pdf/2021-26733.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment." The purpose of this draft guidance is to assist...

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